PT1556026E - Novas formulações farmacêuticas de modafinil - Google Patents

Novas formulações farmacêuticas de modafinil Download PDF

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Publication number
PT1556026E
PT1556026E PT03752264T PT03752264T PT1556026E PT 1556026 E PT1556026 E PT 1556026E PT 03752264 T PT03752264 T PT 03752264T PT 03752264 T PT03752264 T PT 03752264T PT 1556026 E PT1556026 E PT 1556026E
Authority
PT
Portugal
Prior art keywords
composition
modafinil
starch
weight
magnesium stearate
Prior art date
Application number
PT03752264T
Other languages
English (en)
Portuguese (pt)
Inventor
Alpa Parikh
Vincent Corvari
George Grandolfi
Original Assignee
Cephalon Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=31991673&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=PT1556026(E) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Cephalon Inc filed Critical Cephalon Inc
Publication of PT1556026E publication Critical patent/PT1556026E/pt

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1617Organic compounds, e.g. phospholipids, fats
    • A61K9/1623Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/16Amides, e.g. hydroxamic acids
    • A61K31/165Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1635Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1652Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • A61K9/2018Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/2027Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/14Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/14Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
    • A61P25/16Anti-Parkinson drugs
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/18Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/26Psychostimulants, e.g. nicotine, cocaine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/28Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/04Anorexiants; Antiobesity agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P39/00General protective or antinoxious agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/10Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Biomedical Technology (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Psychiatry (AREA)
  • Diabetes (AREA)
  • Psychology (AREA)
  • Obesity (AREA)
  • Hematology (AREA)
  • Vascular Medicine (AREA)
  • Child & Adolescent Psychology (AREA)
  • Hospice & Palliative Care (AREA)
  • Toxicology (AREA)
  • Urology & Nephrology (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Pulmonology (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
PT03752264T 2002-09-13 2003-09-11 Novas formulações farmacêuticas de modafinil PT1556026E (pt)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US10/243,557 US7229644B2 (en) 2002-05-23 2002-09-13 Pharmaceutical formulations of modafinil

Publications (1)

Publication Number Publication Date
PT1556026E true PT1556026E (pt) 2009-07-23

Family

ID=31991673

Family Applications (1)

Application Number Title Priority Date Filing Date
PT03752264T PT1556026E (pt) 2002-09-13 2003-09-11 Novas formulações farmacêuticas de modafinil

Country Status (28)

Country Link
US (1) US7229644B2 (de)
EP (1) EP1556026B1 (de)
JP (2) JP5415662B2 (de)
KR (1) KR101125361B1 (de)
CN (2) CN101606915B (de)
AR (1) AR041242A1 (de)
AT (1) ATE434435T1 (de)
AU (1) AU2003270563B2 (de)
BR (1) BR0314515A (de)
CA (1) CA2498506C (de)
CY (1) CY1109465T1 (de)
DE (1) DE60328119D1 (de)
DK (1) DK1556026T3 (de)
EA (1) EA008506B1 (de)
ES (1) ES2325860T3 (de)
IL (1) IL167187A (de)
IS (1) IS2707B (de)
MX (1) MXPA05002832A (de)
MY (1) MY140081A (de)
NO (1) NO333725B1 (de)
NZ (1) NZ538940A (de)
PL (1) PL375831A1 (de)
PT (1) PT1556026E (de)
SI (1) SI1556026T1 (de)
TW (1) TWI316406B (de)
UA (1) UA88867C2 (de)
WO (1) WO2004024133A1 (de)
ZA (1) ZA200502792B (de)

Families Citing this family (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ES2277937T3 (es) 2000-07-27 2007-08-01 Teva Pharmaceutical Industries Ltd. Modafinilo puro y cristalino y su procedimiento de preparacion.
US20080058424A1 (en) * 2002-05-23 2008-03-06 Cephalon, Inc. Novel pharmaceutical formulations of modafinil
US7229644B2 (en) * 2002-05-23 2007-06-12 Cephalon, Inc. Pharmaceutical formulations of modafinil
US20040116532A1 (en) 2002-09-13 2004-06-17 Craig Heacock Pharmaceutical formulations of modafinil
FR2849029B1 (fr) * 2002-12-20 2005-03-18 Lafon Labor Procede de preparation et formes cristallines des enantiomeres optiques du modafinil.
US20040253308A1 (en) * 2003-04-29 2004-12-16 Barr Laboratories, Inc. Surface-treated modafinil particles
US8153159B2 (en) * 2003-09-18 2012-04-10 Cephalon, Inc. Modafinil modified release pharmaceutical compositions
US7368591B2 (en) 2003-09-19 2008-05-06 Cephalon France Process for enantioselective synthesis of single enantiomers of modafinil by asymmetric oxidation
US20050137264A1 (en) * 2003-12-22 2005-06-23 Patel Ashish A. Modafinil compositions
US20060024370A1 (en) 2004-07-29 2006-02-02 Cephalon France Modafinil oral lyophilizate
US8173169B2 (en) * 2007-07-11 2012-05-08 Hikma Pharmaceuticals Formulation and process for the preparation of modafinil
EP3002005A1 (de) * 2014-09-30 2016-04-06 Molkerei Meggle Wasserburg GmbH & Co. Kg Direktkomprimierter Hilfsstoff auf Basis von Lactose, Cellulose und Stärke
US9616068B2 (en) 2014-10-27 2017-04-11 Pohela LLC Animal training using cognitive enhancement
FR3117775B1 (fr) * 2020-12-18 2024-04-19 Commissariat Energie Atomique Produit pharmaceutique, son procédé de préparation et ses utilisations

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HU187215B (en) * 1983-01-26 1985-11-28 Egyt Gyogyszervegyeszeti Gyar Method for producing pharmaceutical product of high actor content and prolonged effect
FR2593809B1 (fr) * 1986-01-31 1988-07-22 Lafon Labor Benzhydrylsulfinylacetamide, procede de preparation et utilisation en therapeutique
FR2663225B1 (fr) * 1990-06-14 1994-11-04 Lafon Labor Nouvelle utilisation du modafinil.
FR2684875B1 (fr) * 1991-12-13 1995-05-24 Lafon Labor Utilisation du modafinil pour la fabrication d'un medicament ayant un effet anti-ischemique.
FR2697162B1 (fr) * 1992-10-23 1995-01-13 Lafon Labor Utilisation du modafinil pour la fabrication d'un médicament pour le traitement de l'incontinence urinaire et des troubles sphinctériens urétro vésicaux.
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US5843347A (en) * 1993-03-23 1998-12-01 Laboratoire L. Lafon Extrusion and freeze-drying method for preparing particles containing an active ingredient
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CA2243237C (en) * 1996-01-19 2008-09-02 Glaxo Group Limited Use of valaciclovir for the manufacture of a medicament for the treatment of genital herpes by a single daily application
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US5948437A (en) * 1996-05-23 1999-09-07 Zeneca Limited Pharmaceutical compositions using thiazepine
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US7576133B2 (en) * 2002-03-11 2009-08-18 Carl Henry Lawyer Methods and compositions for nasal administration of modafinil
US7229644B2 (en) * 2002-05-23 2007-06-12 Cephalon, Inc. Pharmaceutical formulations of modafinil
US7115281B2 (en) 2002-07-08 2006-10-03 Ranbaxy Laboratories Limited Processes for the preparation of oral dosage formulations of modafinil
EP1526842A1 (de) 2002-07-25 2005-05-04 Ranbaxy Laboratories, Ltd. Verfahren zur herstellung oraler modafinilarzneimittel
US20040116532A1 (en) * 2002-09-13 2004-06-17 Craig Heacock Pharmaceutical formulations of modafinil

Also Published As

Publication number Publication date
JP5415662B2 (ja) 2014-02-12
ATE434435T1 (de) 2009-07-15
UA88867C2 (ru) 2009-12-10
US7229644B2 (en) 2007-06-12
TWI316406B (en) 2009-11-01
ES2325860T3 (es) 2009-09-22
CN101606915A (zh) 2009-12-23
PL375831A1 (en) 2005-12-12
ZA200502792B (en) 2006-03-29
MXPA05002832A (es) 2005-08-16
CY1109465T1 (el) 2014-08-13
EA200500486A1 (ru) 2005-08-25
CN101606915B (zh) 2012-01-11
DK1556026T3 (da) 2009-08-24
EP1556026A1 (de) 2005-07-27
EP1556026B1 (de) 2009-06-24
AR041242A1 (es) 2005-05-11
HK1078265A1 (en) 2006-03-10
JP2006501270A (ja) 2006-01-12
IS7715A (is) 2005-02-24
WO2004024133A1 (en) 2004-03-25
BR0314515A (pt) 2005-08-09
TW200500097A (en) 2005-01-01
NO333725B1 (no) 2013-09-02
IL167187A (en) 2010-12-30
DE60328119D1 (de) 2009-08-06
IS2707B (is) 2011-01-15
WO2004024133B1 (en) 2004-05-06
AU2003270563B2 (en) 2008-11-13
NZ538940A (en) 2008-07-31
CN100528150C (zh) 2009-08-19
EA008506B1 (ru) 2007-06-29
US20030220403A1 (en) 2003-11-27
AU2003270563A1 (en) 2004-04-30
MY140081A (en) 2009-11-30
KR101125361B1 (ko) 2012-03-27
JP2014028833A (ja) 2014-02-13
KR20050053648A (ko) 2005-06-08
CA2498506C (en) 2012-01-03
SI1556026T1 (sl) 2009-12-31
CN1681485A (zh) 2005-10-12
CA2498506A1 (en) 2004-03-25
NO20051138L (no) 2005-03-21

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